Pain, BackNCT03880500
Spinal Segment MRI Perfusion and Diffusion Response to Spinal Manipulation in Low Back Pain Patients
A study testing Spinal Manipulative Therapy in people with Pain, Back, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
The main objective is to quantify changes in diffusion and perfusion in the intervertebral disc and adjacent spinal muscle tissue of a spinal segment receiving a spinal manipulative or control intervention using diffusion-weighted magnetic resonance Imaging (MRI) (DWI, used for quantifying diffusion) and intravoxel… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Back
- What is being tested?
- Spinal Manipulative Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Mar 2019to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- Persons over 18 years and under 75 years of age with low back pain of any duration clinically not attributable to "red flags" (infection, trauma, fractures, inflammatory illnesses).
- Source of LBP clinically at the L4/5 or L5/S1 segment.
- Duration of LBP is longer than 4 weeks
- Obtained informed consent.
- Controls:
- Persons over 18 years and under 75 years of age who have not suffered from low back pain in the last year and have never experienced low back pain for longer than 7 consecutive days.
- Obtained informed consent.
Who cannot join
- Subjects are excluded from enrolment if they
- have undergone prior spinal surgery
- have undergone facet joint, epidural or periradicular injections in the last 6 months
- had a spinal manipulative therapy intervention in the past 2 weeks
- have spinal abnormalities (benign or malignant tumors, congenital abnormalities, isthmic spondylolisthesis)
- have any contraindication to spinal manipulative interventions or are deemed unable to tolerate SMT to both body sides (e.g. pain attributable to above mentioned red flags, inability to perform side-lying without pain, radiculopathy with motor deficits <M4-, severe spinal canal stenosis)
Show all 10Show fewer
- have any contraindication to MRI (e.g. heart pacemaker, metallic foreign body or claustrophobia)
- have started a new prescription medication targeting blood circulation within the last 3 months
- are pregnant or nursing
- Subjects are excluded from venipuncture if they are known to be HIV-positive or have Hepatitis A, B, or C or have another systemic infection (excludes subjects from venipuncture). No study specific testing for HIV or Hepatitis A, B or C is performed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Balgrist
Zurich, Canton of Zurich, 8008
Petra Schweinhardt, MD PhD, 0041443861111, petra.schweinhardt@balgrist.ch
About this study
Official title: MRI-quantified Changes in Perfusion and Diffusion in Spinal Segments After High-Velocity, Low-Amplitude Spinal Manipulation: A Randomized Controlled Trial
The main objective is to quantify changes in diffusion and perfusion in the intervertebral disc and adjacent spinal muscle tissue of a spinal segment receiving a spinal manipulative or control intervention using diffusion-weighted magnetic resonance Imaging (MRI) (DWI, used for quantifying diffusion) and intravoxel incoherent motion MRI (IVIM, used for quantifying perfusion).
Additional objectives are to test if clinical parameters such as pain and disability, radiological parameters, or pain-related inflammatory parameters in venous blood have predictive value in relation to these perfusion and diffusion effects, and if these effects correlate to clinical outcome.
An additional objective is to test the repeatability of IVIM-MRI in assessing perfusion changes in musculoskeletal tissue, and, as a positive control, assessing diurnal changes in perfusion and diffusion parameters in spinal tissue of healthy controls.
Read the detailed description
Non-specific low back pain (LBP) is a very common condition in developed countries, with a point prevalence between 15% and 30% and a lifetime prevalence of about 70%. As a non-invasive treatment method, high-velocity, low-amplitude spinal manipulative therapy (SMT) is used in the conservative treatment of non-specific low back pain (LBP). Several studies suggest an association with favourable outcome. However, the overall effect size of clinical improvement following SMT remains modest. Most research on the effectiveness of SMT on back pain is conducted on patients suffering from "non-specific" LBP, the diagnosis of which is usually based upon the criterium that pain is not attributed to a recognizable pathology (e.g., infection, tumor, inflammatory diseases, fractures, disc herniations with nerve compression)8. In most of these studies, it is unclear whether patients' diagnoses were based upon more than history and clinical examination. The investigators argue that in the majority of cases, back pain labelled as non-specific might be more accurately labelled as non-specified and does have an attributable source and cause, whether one is able to recognize it or not. Therefore, if the diagnosis of non-specific LBP comprises heterogenic conditions, it is unlikely that patients will respond to one therapeutic modality equally.
Diffusion-weighted MR-imaging (DWI) is an application of magnetic resonance imaging that allows the measurement of water movement within and between tissues and is increasingly being used to study musculoskeletal physiology. Because DWI is sensitive even to small changes in fluid flow, it is potentially valuable in the study of the influence of therapeutic interventions such as manual therapy, exercise, and physical agents on musculoskeletal tissues. Studies using DWI have suggested that changes in diffusion within lumbar intervertebral discs occur in response to joint mobilization, prone press-ups, spinal traction and spinal manipulative therapy.
Intravoxel incoherent motion (IVIM) is a method proposed in 1988 by Le Bihan et al. which extracts microvascular blood flow information from diffusion-weighted imaging acquired at different b-values. It is used to generate separate images of diffusion and perfusion without requiring the injection of exogenous contrast agents. Originally developed in brain studies, it has been used in recent years to study perfusion in musculoskeletal tissue. There is a paucity of research addressing physiological events following a SMT intervention for patients with low back pain. A deeper understanding of local biomechanical and neurophysiological effects of SMT interventions might help refine its utilization and improve its effectiveness.
The purpose of this study is to quantify changes in diffusion and perfusion parameters within the intervertebral disc and paraspinal muscle tissue of a spinal segment receiving a spinal manipulative or sham intervention and to evaluate whether those changes differ in spinal segments with or without degenerative changes in 50 low-back-pain patients.
Additionally, it is of interest to determine the relationships between baseline parameters and changes in diffusion and perfusion as well as the degree of degenerative changes. Post-intervention changes in segmental spinal muscle perfusion will also be investigated. There will be a clinical follow-up immediately after the second MRI and at 1 week,4 and 12 weeks.
The repeatability and diurnal variation of IVIM imaging in quantifying perfusion in musculoskeletal tissues will be assessed by comparing perfusion parameters of 20 controls who will not receive any intervention. The investigators will perform a diffusion- and perfusion-weighted MRI at the beginning of the visit in the morning, which is repeated after approximately 20 minutes of rest (lying supine). Controls will present for an additional MRI approximately 10 hours later in the evening of the same day.
In participants consenting to venipuncture, approximately 8 ml of venous blood will be withdrawn using serum collection tubes, allowed to clot, and then centrifuged. The resulting serum supernatant is stored in aliquots at Balgrist Campus at -80°C. It will be analysed at the end of data collection for pro- and anti-inflammatory markers (e.g. C-reactive Protein, Interleukin 1-beta, Interleukin 6 and Tumor Necrosis Factor) in order to determine the relationship between inflammatory markers and degenerative changes, pain duration, and pain and disability outcomes.
- Conditions
- Pain, Back
- Being tested
- Spinal Manipulative Therapy
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Manipulative TherapyOther
Also called SMT, Spinal Manipulative Intervention, Thrust Manipulation, High-velocity, low-amplitude thrust
The patient lies in sidelying position, with the hip of the upper leg flexed to 90° and the foot of the flexed leg hooked behind the popliteal space of the downside leg. The chiropractor faces the subject at a 45°-angle, fixates the flexed knee with his own knee/thigh. The fingers of the cephalic hand reach under the patient's upper arm to contact the upside lateral surface of the superior spinous process. The fingers of the caudal hand hook down-side aspect of the spinous process, the forearm contacts the patient's buttock and thigh. The cephalic hand thrusts lateromedially and caudocranially, from upside toward downside (push). The caudal hand thrusts lateromedially in the opposing direction, from downside toward upside (pull). SMT is repeated after the patient turns to left side lying.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Sham comparator | 25 Patients will receive a spinal manipulative therapy Intervention, the other 25 Patients receive a sham Intervention. Receives: Other: Spinal Manipulative Therapy |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparent Diffusion Coefficient Change
Computed on diffusion-weighted MRI, refers to the mean diffusion in a voxel (on MRI). Apparent diffusion coefficient (ADC) is measured in the intervertebral disc and adjacent spinal muscle tissue in patients before and after an SMT- or control intervention and in controls before and after 20 minutes of lying supine. The computed difference is the Apparent Diffusion Coefficient Change.
Measured: Measured on day 1 during the study
Capillary Perfusion Change
Also called pseudodiffusion or D*. Measured on IVIM-MRI in square millimeters per second. Perfusion in capillaries in spinal muscle tissue is measured in patients before and after an SMT- or control intervention and in controls before and after 20 minutes of lying supine. The computed difference equals the Capillary Perfusion Change.
Measured: Measured on day 1 during the study
Diffusion Change
Measured on diffusion-weighted MRI in square millimeters per second. Diffusion (D) in intra- and extracellular compartments in the intervertebral disc and adjacent spinal muscle tissue is measured in patients before and after an SMT- or control intervention and in controls before and after 20 minutes of lying supine. The computed difference is the Diffusion Change.
Measured: Measured on day 1 during the study
Secondary outcomes (3)
Change in Apparent Diffusion Coefficient (Control)
Measured on MRI. Secondary outcomes are the diurnal changes of the apparent diffusion coefficient in musculoskeletal tissue in controls approximately 9 hours after the first MRI.
Measured: Measured approximately 9 hours after the first MRI, during the study
Change in Capillary Perfusion (Control)
Secondary outcomes are the diurnal changes of capillary perfusion in musculoskeletal tissue in controls approximately 9 hours after the first MRI.
Measured: Measured approximately 9 hours after the first MRI, during the study
Diffusion change
Secondary outcomes are the diurnal changes of diffusion in the intervertebral disc and adjacent spinal muscle tissue in controls approximately 9 hours after the first MRI.
Measured: Measured approximately 9 hours after the first MRI, during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start6 Mar 2019
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain, BackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 20 Controls, 50 Patients
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Verein Pro Chiropraktik, Balgrist Foundation
- Responsible party
- Sponsor
- Investigators
- Petra Schweinhardt, PhD, MD, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880500
- Sponsor's protocol ID
- BalgristUH
- Status last verified
- Aug 2023
- First submitted
- 6 Dec 2018
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beattie PF, Butts R, Donley JW, Liuzzo DM. The within-session change in low back pain intensity following spinal manipulative therapy is related to differences in diffusion of water in the intervertebral discs of the upper lumbar spine and L5-S1. J Orthop Sports Phys Ther. 2014 Jan;44(1):19-29. doi: 10.2519/jospt.2014.4967. Epub 2013 Nov 21.
PubMed 24261925Le Bihan D. What can we see with IVIM MRI? Neuroimage. 2019 Feb 15;187:56-67. doi: 10.1016/j.neuroimage.2017.12.062. Epub 2017 Dec 22.
PubMed 29277647Nguyen A, Ledoux JB, Omoumi P, Becce F, Forget J, Federau C. Application of intravoxel incoherent motion perfusion imaging to shoulder muscles after a lift-off test of varying duration. NMR Biomed. 2016 Jan;29(1):66-73. doi: 10.1002/nbm.3449.
PubMed 26684052Wong AY, Parent EC, Dhillon SS, Prasad N, Kawchuk GN. Do participants with low back pain who respond to spinal manipulative therapy differ biomechanically from nonresponders, untreated controls or asymptomatic controls? Spine (Phila Pa 1976). 2015 Sep 1;40(17):1329-37. doi: 10.1097/BRS.0000000000000981.
PubMed 26020851Klyne DM, Barbe MF, Hodges PW. Systemic inflammatory profiles and their relationships with demographic, behavioural and clinical features in acute low back pain. Brain Behav Immun. 2017 Feb;60:84-92. doi: 10.1016/j.bbi.2016.10.003. Epub 2016 Oct 6.
PubMed 27720935Chou R, Huffman LH; American Pain Society; American College of Physicians. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):492-504. doi: 10.7326/0003-4819-147-7-200710020-00007.
PubMed 17909210
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-quantified Changes in Perfusion and Diffusion in Spinal Segments After High-Velocity, Low-Amplitude Spinal Manipulation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03880500
- Acronym / sponsor ID
- BalgristUH
- Conditions
- Pain, Back
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Verein Pro Chiropraktik, Balgrist Foundation
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to quantify changes in diffusion and perfusion in the intervertebral disc and adjacent spinal muscle tissue of a spinal segment receiving a spinal manipulative or control intervention using diffusion-weighted magnetic resonance Imaging (MRI) (DWI, used for quantifying diffusion) and intravoxel incoherent motion MRI (IVIM, used for quantifying perfusion).
Additional objectives are to test if clinical parameters such as pain and disability, radiological parameters, or pain-related inflammatory parameters in venous blood have predictive value in relation to these perfusion and diffusion effects, and if these effects correlate to clinical outcome.
An additional objective is to test the repeatability of IVIM-MRI in assessing perfusion changes in musculoskeletal tissue, and, as a positive control, assessing diurnal changes in perfusion and diffusion parameters in spinal tissue of healthy controls.
Detailed description
Non-specific low back pain (LBP) is a very common condition in developed countries, with a point prevalence between 15% and 30% and a lifetime prevalence of about 70%. As a non-invasive treatment method, high-velocity, low-amplitude spinal manipulative therapy (SMT) is used in the conservative treatment of non-specific low back pain (LBP). Several studies suggest an association with favourable outcome. However, the overall effect size of clinical improvement following SMT remains modest. Most research on the effectiveness of SMT on back pain is conducted on patients suffering from "non-specific" LBP, the diagnosis of which is usually based upon the criterium that pain is not attributed to a recognizable pathology (e.g., infection, tumor, inflammatory diseases, fractures, disc herniations with nerve compression)8. In most of these studies, it is unclear whether patients' diagnoses were based upon more than history and clinical examination. The investigators argue that in the majority of cases, back pain labelled as non-specific might be more accurately labelled as non-specified and does have an attributable source and cause, whether one is able to recognize it or not. Therefore, if the diagnosis of non-specific LBP comprises heterogenic conditions, it is unlikely that patients will respond to one therapeutic modality equally.
Diffusion-weighted MR-imaging (DWI) is an application of magnetic resonance imaging that allows the measurement of water movement within and between tissues and is increasingly being used to study musculoskeletal physiology. Because DWI is sensitive even to small changes in fluid flow, it is potentially valuable in the study of the influence of therapeutic interventions such as manual therapy, exercise, and physical agents on musculoskeletal tissues. Studies using DWI have suggested that changes in diffusion within lumbar intervertebral discs occur in response to joint mobilization, prone press-ups, spinal traction and spinal manipulative therapy.
Intravoxel incoherent motion (IVIM) is a method proposed in 1988 by Le Bihan et al. which extracts microvascular blood flow information from diffusion-weighted imaging acquired at different b-values. It is used to generate separate images of diffusion and perfusion without requiring the injection of exogenous contrast agents. Originally developed in brain studies, it has been used in recent years to study perfusion in musculoskeletal tissue. There is a paucity of research addressing physiological events following a SMT intervention for patients with low back pain. A deeper understanding of local biomechanical and neurophysiological effects of SMT interventions might help refine its utilization and improve its effectiveness.
The purpose of this study is to quantify changes in diffusion and perfusion parameters within the intervertebral disc and paraspinal muscle tissue of a spinal segment receiving a spinal manipulative or sham intervention and to evaluate whether those changes differ in spinal segments with or without degenerative changes in 50 low-back-pain patients.
Additionally, it is of interest to determine the relationships between baseline parameters and changes in diffusion and perfusion as well as the degree of degenerative changes. Post-intervention changes in segmental spinal muscle perfusion will also be investigated. There will be a clinical follow-up immediately after the second MRI and at 1 week,4 and 12 weeks.
The repeatability and diurnal variation of IVIM imaging in quantifying perfusion in musculoskeletal tissues will be assessed by comparing perfusion parameters of 20 controls who will not receive any intervention. The investigators will perform a diffusion- and perfusion-weighted MRI at the beginning of the visit in the morning, which is repeated after approximately 20 minutes of rest (lying supine). Controls will present for an additional MRI approximately 10 hours later in the evening of the same day.
In participants consenting to venipuncture, approximately 8 ml of venous blood will be withdrawn using serum collection tubes, allowed to clot, and then centrifuged. The resulting serum supernatant is stored in aliquots at Balgrist Campus at -80°C. It will be analysed at the end of data collection for pro- and anti-inflammatory markers (e.g. C-reactive Protein, Interleukin 1-beta, Interleukin 6 and Tumor Necrosis Factor) in order to determine the relationship between inflammatory markers and degenerative changes, pain duration, and pain and disability outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 20 Controls, 50 Patients
| Arm | Type | Receives |
|---|---|---|
| Patient | Sham comparator | Other: Spinal Manipulative Therapy25 Patients will receive a spinal manipulative therapy Intervention, the other 25 Patients receive a sham Intervention. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Persons over 18 years and under 75 years of age with low back pain of any duration clinically not attributable to "red flags" (infection, trauma, fractures, inflammatory illnesses).
- Source of LBP clinically at the L4/5 or L5/S1 segment.
- Duration of LBP is longer than 4 weeks
- Obtained informed consent.
- Persons over 18 years and under 75 years of age who have not suffered from low back pain in the last year and have never experienced low back pain for longer than 7 consecutive days.
Key exclusion criteria (10 listed)
- Subjects are excluded from enrolment if they
- have undergone prior spinal surgery
- have undergone facet joint, epidural or periradicular injections in the last 6 months
- had a spinal manipulative therapy intervention in the past 2 weeks
- have spinal abnormalities (benign or malignant tumors, congenital abnormalities, isthmic spondylolisthesis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Manipulative TherapyAlso: SMT, Spinal Manipulative Intervention, Thrust Manipulation, High-velocity, low-amplitude thrustThe patient lies in sidelying position, with the hip of the upper leg flexed to 90° and the foot of the flexed leg hooked behind the popliteal space of the downside leg. The chiropractor faces the subject at a 45°-angle, fixates the flexed knee with his own knee/thigh. The fingers of the cephalic hand reach under the patient's upper arm to contact the upside lateral surface of the superior spinous process. The fingers of the caudal hand hook down-side aspect of the spinous process, the forearm contacts the patient's buttock and thigh. The cephalic hand thrusts lateromedially and caudocranially, from upside toward downside (push). The caudal hand thrusts lateromedially in the opposing direction, from downside toward upside (pull). SMT is repeated after the patient turns to left side lying. | Other | Patient |
Primary outcome
Apparent Diffusion Coefficient Change
Time frame: Measured on day 1 during the study
Computed on diffusion-weighted MRI, refers to the mean diffusion in a voxel (on MRI). Apparent diffusion coefficient (ADC) is measured in the intervertebral disc and adjacent spinal muscle tissue in patients before and after an SMT- or control intervention and in controls before and after 20 minutes of lying supine. The computed difference is the Apparent Diffusion Coefficient Change.
Capillary Perfusion Change
Time frame: Measured on day 1 during the study
Also called pseudodiffusion or D*. Measured on IVIM-MRI in square millimeters per second. Perfusion in capillaries in spinal muscle tissue is measured in patients before and after an SMT- or control intervention and in controls before and after 20 minutes of lying supine. The computed difference equals the Capillary Perfusion Change.
Diffusion Change
Time frame: Measured on day 1 during the study
Measured on diffusion-weighted MRI in square millimeters per second. Diffusion (D) in intra- and extracellular compartments in the intervertebral disc and adjacent spinal muscle tissue is measured in patients before and after an SMT- or control intervention and in controls before and after 20 minutes of lying supine. The computed difference is the Diffusion Change.
3 secondary outcomes
Change in Apparent Diffusion Coefficient (Control)
Time frame: Measured approximately 9 hours after the first MRI, during the study
Change in Capillary Perfusion (Control)
Time frame: Measured approximately 9 hours after the first MRI, during the study
Diffusion change
Time frame: Measured approximately 9 hours after the first MRI, during the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 24261925Beattie PF, Butts R, Donley JW, Liuzzo DM. The within-session change in low back pain intensity following spinal manipulative therapy is related to differences in diffusion of water in the intervertebral discs of the upper lumbar spine and L5-S1. J Orthop Sports Phys Ther. 2014 Jan;44(1):19-29. doi: 10.2519/jospt.2014.4967. Epub 2013 Nov 21.
- Background: PubMed 29277647Le Bihan D. What can we see with IVIM MRI? Neuroimage. 2019 Feb 15;187:56-67. doi: 10.1016/j.neuroimage.2017.12.062. Epub 2017 Dec 22.
- Background: PubMed 26684052Nguyen A, Ledoux JB, Omoumi P, Becce F, Forget J, Federau C. Application of intravoxel incoherent motion perfusion imaging to shoulder muscles after a lift-off test of varying duration. NMR Biomed. 2016 Jan;29(1):66-73. doi: 10.1002/nbm.3449.
- Background: PubMed 26020851Wong AY, Parent EC, Dhillon SS, Prasad N, Kawchuk GN. Do participants with low back pain who respond to spinal manipulative therapy differ biomechanically from nonresponders, untreated controls or asymptomatic controls? Spine (Phila Pa 1976). 2015 Sep 1;40(17):1329-37. doi: 10.1097/BRS.0000000000000981.
- Background: PubMed 27720935Klyne DM, Barbe MF, Hodges PW. Systemic inflammatory profiles and their relationships with demographic, behavioural and clinical features in acute low back pain. Brain Behav Immun. 2017 Feb;60:84-92. doi: 10.1016/j.bbi.2016.10.003. Epub 2016 Oct 6.
- Background: PubMed 17909210Chou R, Huffman LH; American Pain Society; American College of Physicians. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):492-504. doi: 10.7326/0003-4819-147-7-200710020-00007.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Schweinhardt, PhD, MD principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulative Therapy in people with Pain, Back, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Malin B Muehlemann, Dr med.chiro (0041443865712, malin.muehlemann@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apparent Diffusion Coefficient Change (time frame: Measured on day 1 during the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03880500, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.